Identity
- Trade Name
- Rheofilter ER EUDAMED
- Device Name
- Plasma Component Separator EUDAMED
- Model / Reference
- ER-4000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04987488102173 EUDAMED
- Basic UDI-DI
- 4987488PCS_ER_RB EUDAMED
- EMDN Code
- B030201 PLASMAPHERESIS DEVICES AND KITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Rheofilter ER by Sb-Kawasumi Laboratories, Inc. — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Unknown
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 4987488PCS_ER_RB | Class IIb | Unknown |
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Manufacturer
- Manufacturer
- Sb-Kawasumi Laboratories, Inc.
- EUDAMED SRN
- JP-MF-000011253
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 5a9b9dee-d672-4c38-bd07-c54fab3583af 61 fields · synced Jun 18, 2026